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Vaccines, Blood & Biologics

Omrix Email - EVARREST, August 2, 2011

From: Sara Horn []
Sent: Tuesday, August 02, 2011 1:56 PM
To: Kelly, Sonday
Cc: Le Chung
Subject: Fibrin Pad BLA

Dear Sonday,

As a follow-up to our previous discussion over the phone today, we would be grateful if you could set

  • A conference call  with you and a representative from DMPQ (Randa Melhem) to further discuss the pathway for providing further information to the responses Omrix submitted on the 483s  and the impact of these responses on the review timelines of the current pending BLA. We would like to have this call next week if possible.
  • A conference call with you and the CMC reviewer (Natalya Ananyeva) to discuss the regulatory comparability strategy for changes we plan to implement post approval. We would like to have this call as soon as possible as this might impact our planned work on these changes that should start in the near future.

Thanks again for your time today

Kind Regards,

Sara Horn, PhD
Distinguished Regulatory Fellow

Omrix Biopharmaceuticals Ltd


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